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  5. Label Information: Betadine Antiseptic Oral Rinse

FDA Label for Betadine Antiseptic Oral Rinse

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. USES
    4. DO NOT USE THIS PRODUCT
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF
    7. OTC - PREGNANCY OR BREAST FEEDING
    8. DIRECTIONS
    9. OTHER INFORMATION
    10. INACTIVE INGREDIENTS
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Betadine Antiseptic Oral Rinse Product Label

The following document was submitted to the FDA by the labeler of this product Atlantis Consumer Healthcare, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts



Active ingredient

Povidone-iodine, 0.5% (0.05% available iodine)


Purpose



Oral Antiseptic


Uses



  • For preparation of the oral mucosa prior to injection, dental surgery, or tooth extraction

Do Not Use This Product



  • for more than 7 days unless directed by a dentist or doctor
  • in children under 12 years of age unless directed by a dentist or doctor
  • if you are allergic to povidone-iodine or any other ingredients in this product
  • if you have any thyroid conditions

When Using This Product



  • do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor
  • do not swallow
  • do not use with hydrogen peroxide

Stop Use And Ask A Doctor If



  • symptoms do not improve in 7 days
  • irritation, pain, or redness persists or worsens
  • swelling, rash, or fever develops

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Directions



  • Use full strength
  • Apply 10 to 20 milliliters of solution to the operative site. Instruct the patient to rinse for 30 seconds and then spit out.
  • Wait 2 minutes, and apply another 10 to 20 milliliters of solution to the operative site. Instruct the patient to rinse again for 30 seconds and then spit out.
  • With a standard syringe and a blunt, angulated needle, irrigate the operative site and the surrounding gingival mucosa for 1 minute with 10 to 20 milliliters of the solution. Instruct the patient to spit out the solution after the irrigation procedure.

Other Information



  • store at 25⁰C (77⁰F); excursions permitted between 15⁰-30⁰C (59⁰-86⁰F)
  • may stain clothing or dental work
  • avoid contact with jewelry, especially silver

Inactive Ingredients



citric acid, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium hydroxide


Package Label.Principal Display Panel



Betadine Oral Rinse
NDC: 67618-182-08

Betadine Oral Rinse label - 305765 0B

Betadine Oral Rinse label - 305765 0B


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